Caire, Inc.
Medical device manufacturer in Ball Ground, GA.
7510(k) clearances
0PMA approvals
12recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort)CAW · Traditional | 07/11/2025SE |
| K120785 | Omni 3 Oxygen SystemCAW · Special | 10/25/2012SE |
| K121167 | Caire Companion 5 Oxygen ConcentratorCAW · Traditional | 05/02/2012SE |
| K080023 | Modification to: SpiritBYJ · Special | 06/16/2008SE |
| K050153 | Spirit, Model HasBYJ · Traditional | 04/15/2005SE |
| K013251 | Spirit 300BYJ · Traditional | 12/18/2001SE |
| K952268 | Model Delta, Om Oxygen ConcentratorCAW · Traditional | 08/11/1995SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0481-2025 Class II | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.Potential failure of affected units to recharge the battery of the oxygen concentrators. | 10/04/2024Completed |
| Z-0480-2025 Class II | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.Potential failure of affected units to recharge the battery of the oxygen concentrators. | 10/04/2024Completed |
| Z-0479-2025 Class II | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.Potential failure of affected units to recharge the battery of the oxygen concentrators. | 10/04/2024Completed |
| Z-0478-2025 Class II | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.Potential failure of affected units to recharge the battery of the oxygen concentrators. | 10/04/2024Completed |
| Z-0339-2023 Class I | CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System UnitAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner… | 10/10/2022Terminated |
| Z-0338-2023 Class I | CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System UnitAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner… | 10/10/2022Terminated |
| Z-0337-2023 Class I | CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System UnitAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner… | 10/10/2022Terminated |
| Z-0336-2023 Class I | CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System UnitAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner… | 10/10/2022Terminated |
| Z-1117-2022 Class II | CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and…The device was not cleared for U.S. distribution. | 03/25/2022Terminated |
| Z-0805-2020 Class II | CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle…Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in… | 11/21/2019Terminated |
| Z-0248-2020 Class II | SAROS Oxygen System Model 3000There is an electronics control issue that causes the unit to not power on with battery power only. | 09/16/2019Terminated |
| Z-1716-2008 | Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and…Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level… | 10/23/2007Terminated |